The Challenges of Biopharmaceutical Products for Analytical Requirements
نویسندگان
چکیده
منابع مشابه
Analytical Challenges and Regulatory Requirements for Nasal Drug Products in Europe and the U.S.
Nasal drug delivery can be assessed by a variety of means and regulatory agencies, e.g., the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have published a set of guidelines and regulations proposing in vitro test methods for the characterization of nasal drug products. This article gives a summary of the FDA and EMA requirements regarding the determination of dropl...
متن کاملstudy of cohesive devices in the textbook of english for the students of apsychology by rastegarpour
this study investigates the cohesive devices used in the textbook of english for the students of psychology. the research questions and hypotheses in the present study are based on what frequency and distribution of grammatical and lexical cohesive devices are. then, to answer the questions all grammatical and lexical cohesive devices in reading comprehension passages from 6 units of 21units th...
New Challenges for Biopharmaceutical Process Development.PDF
The U.S. Food and Drug Administration (FDA), through the Center for Biologics Evaluation and Research (CBER)/Center for Drug Evaluation and Research (CDER), has long identified that the development of biopharmaceutical products is becoming increasingly challenging, and is inefficient and costly. The agency has also commented that superior product-development sciences are needed to address the c...
متن کاملStandardization and Certification Challenges for Biopharmaceutical Plants
C O M P U T E R 0 0 1 8 9 1 6 2 / 1 7 / $ 3 3 . 0 0 © 2 0 1 7 I E E E P U B L I S H E D B Y T H E I E E E C O M P U T E R S O C I E T Y S E P T E M B E R 2 0 1 7 83 Bioprocessing—a technique that produces biological material, such as genetically engineered microbial strains and commercially useful chemicals—is big business in the US and growing quickly around the world. An increasing number of ...
متن کاملthe use of appropriate madm model for ranking the vendors of mci equipments using fuzzy approach
abstract nowadays, the science of decision making has been paid to more attention due to the complexity of the problems of suppliers selection. as known, one of the efficient tools in economic and human resources development is the extension of communication networks in developing countries. so, the proper selection of suppliers of tc equipments is of concern very much. in this study, a ...
15 صفحه اولذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: Pharmaceutica Analytica Acta
سال: 2012
ISSN: 2153-2435
DOI: 10.4172/2153-2435.1000e110